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The Effect of Growth Hormone in Very Young Girls With Turner Syndrome
This study has been completed.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00406926
  Purpose

This study investigated the effect of growth hormone on the growth of infants and toddlers with Turner syndrome during 2 years of treatment with growth hormone. This was compared with the growth of infants and toddlers with Turner syndrome who did not receive any growth hormone treatment. The overall aim was to prevent the growth failure usually seen during this period. The study also looked at middle ear disease, hearing problems, and cognitive and behavioral development.


Condition Intervention Phase
Turner Syndrome
Drug: Somatropin
Phase III

Genetics Home Reference related topics: Turner syndrome
MedlinePlus related topics: Turner Syndrome
Drug Information available for: Somatotropin Somatropin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Effect of Recombinant Human Growth Hormone Treatment on the Growth of Infants and Toddlers With Turner Syndrome

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Height at the end of two years in the study.

Secondary Outcome Measures:
  • Middle ear problems assessed every 4 months
  • Hearing problems assessed annually
  • Cognitive and behavioral development assessed annually

Estimated Enrollment: 100
Study Start Date: August 1999
Estimated Study Completion Date: August 2003
  Eligibility

Ages Eligible for Study:   9 Months to 4 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karyotype-proven Turner syndrome that included a documented abnormality of the short arm of an X chromosome.
  • At least 9 months of age and not greater than 4 years of age.
  • Normal values for age for hemoglobin, thyroid stimulating hormone (TSH) and urinalysis (office dipstick is adequate), performed prior to study entry.
  • If there was a known history of hypothyroidism, then adequate thyroid hormone replacement must have been taken for at least 6 months prior to study entry.

Exclusion Criteria:

  • Current or previous treatment with any therapy that may have directly influenced growth, including growth hormone, growth hormone-releasing hormone, estrogens and anabolic steroids such as oxandrolone. This included previous completion of, or withdrawal from, this study or any other study investigating therapeutic uses of growth hormone or growth hormone-releasing hormone.
  • Chronic treatment with systemic glucocorticoids in supra-physiological doses.
  • Treatment with potential growth-influencing medications such as methylphenidate (Ritalin), pemoline (Cylert), and amphetamines, at, or within 3 months prior to, study entry.
  • Presence of any Y chromosome component in the karyotype if gonads were in situ. Subjects whose karyotype contained Y chromatin, but who had undergone gonadectomy, were eligible to enter the study.
  • Presence of any additional known autosomal abnormality.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406926

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90027
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stanford, California, United States, 94305
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver, Colorado, United States, 80218
United States, Connecticut
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hartford, Connecticut, United States, 06106
United States, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, United States, 60614
United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46202
United States, Kentucky
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lexington, Kentucky, United States, 40536
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kansas City, Missouri, United States, 64108
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Study ID Numbers: 2878, B9R-US-GDFG
Study First Received: November 29, 2006
Last Updated: November 29, 2006
ClinicalTrials.gov Identifier: NCT00406926  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Chromosomal abnormalities
Genital dwarfism
Gonadal Disorders
Chromosome Disorders
Endocrine System Diseases
Sex Differentiation Disorders
Monosomy X
Turner Syndrome
Gonadal dysgenesis
Urogenital Abnormalities
Genetic Diseases, Inborn
Turner syndrome
Ovarian dwarfism
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Sex Chromosome Disorders

ClinicalTrials.gov processed this record on January 16, 2009